Overview Detailed Agenda Speaker Price/Registration Venue
Course Agenda
Day One (8:30AM - 5:00PM)
8:00 – 8:30 AM: Registration 8:30 – 10:00 AM: What is Quality?
10:00 – 10:15 AM: Break 10:15 AM – 12:00 noon: What is Quality (continued)
11:00 – 11:30 AM: Group exercise: Quality system design 12:00 noon – 1:00 PM: Lunch 1:00 – 2:30 PM: What is Regulatory Compliance?
2:30 – 2:45 PM: Break 2:45 – 5:00 PM: What is Regulatory Compliance (continued)
2:45 – 3:15 PM: Group exercise: Medical Device Classification Exercise |
Day Two (8:30 AM - 5:00PM)
8:30 – 10:00AM: FDA and EU Regulatory Compliance
10:00 – 10:15AM: Break 10:15 – 12:00 noon: FDA and EU Regulatory Compliance (continued)
11:00 – 11:30 AM: Group exercise: FDA Regulatory Exercise 12:00 noon – 1:00 PM: Lunch 1:00 – 2:30 PM: Quality Audits
2:15 – 2:30PM: Break 2:30 – 5:00 PM: Quality Audits (continued)
4:30 – 5:00 PM: Group exercise: FDA Compliance Exercise |